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A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats (OPTION-VMS Trial)

N/A
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4, 8, 12, 24 and 52
Awards & highlights
No Placebo-Only Group

Summary

This trial is for menopausal women suffering from hot flashes and night sweats. They will use non-hormonal treatments prescribed by their doctors for several months. The study aims to see if these symptoms improve over time and also looks at sleep, work productivity, and overall well-being.

Eligible Conditions
  • Hot Flashes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 8, 12, 24 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 8, 12, 24 and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from baseline to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score
Secondary study objectives
Change from baseline in average daily number of nighttime awakenings, as recorded by wearable device
Change from baseline in average daily sleep efficiency, as recorded by wearable device
Change from baseline in average daily sleep latency, as recorded by wearable device
+21 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Selective serotonin reuptake inhibitor (SSRI)/Serotonin and norepinephrine reuptake inhibitor (SNRI)Experimental Treatment6 Interventions
Participants prescribed SSRI/SNRI for the treatment of VMS.
Group II: OtherExperimental Treatment5 Interventions
Participants prescribed something other than NK3-R Antagonist or SSRI/SNRI for the treatment of VMS.
Group III: Neurokinin 3 Receptor (NK3-R) AntagonistExperimental Treatment1 Intervention
Participants prescribed NK3-R Antagonist for the treatment of VMS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Desvenlafaxine
2022
Completed Phase 4
~3627000
Oxybutynin
2015
Completed Phase 4
~2750
Clonidine
2010
Completed Phase 4
~1890
Citalopram
2010
Completed Phase 4
~3258800
Gabapentin
2013
Completed Phase 4
~1550
Venlafaxine
2007
Completed Phase 4
~3259640
Pregabalin
2005
Completed Phase 4
~6110
Fezolinetant
2020
Completed Phase 3
~1560
Paroxetine
2002
Completed Phase 4
~3259440
Escitalopram
2005
Completed Phase 4
~2330

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
121,184 Total Patients Enrolled
6 Trials studying Hot Flashes
4,208 Patients Enrolled for Hot Flashes
Central ContactStudy DirectorAstellas Pharma Global Development, Inc.
100 Previous Clinical Trials
6,396,703 Total Patients Enrolled
~519 spots leftby Feb 2026
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